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Company must pay $1.1 billion after recall

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Medical device company Philips settled Monday to provide $1.1 billion to cover hundreds of personal injury lawsuits related to its breathing and sleep apnea machines.

The manufacturer has recalled more than 15 million respirators since 2021, mainly due to health risks caused by the breakdown of foam materials that users could inhale, according to the Food and Drug Administration.

The problems largely involve the brand's popular DreamStation CPAP, or continuous positive airway pressure, machines used to treat sleep apnea and other nighttime breathing problems at home and in healthcare settings.

Philips did not admit any fault as part of the settlement and did not accept any liability for the reported injuries. However, the company said in a statement that the settlement was made to “end the uncertainty associated with litigation in the US.”

This personal injury settlement comes after several other hits in the wallet of Philips Respironics in recent years. In September last year, Philips agreed to a preliminary settlement of $445 million in economic losses to compensate users who had to replace their devices. In April, the company also agreed to a consent decree that halted production in the US

“Patient safety and quality are our top priorities and we have taken important steps to further resolve the impact of the Respironics recall,” Roy Jakobs, CEO of Royal Philips, said in a statement. “The approved consent decree and economic loss settlement, and now the resolution of the US personal injury and medical monitoring lawsuits, are important milestones and provide further clarity on the path forward for Philips.”

Who receives money?

The money from the settlement will be sent to those who use the now-recalled CPAP and “other ventilators who suffer significant physical harm,” plaintiff's attorneys Sandra Duggan, Kelly Iverson, Christopher Seeger and Steven Schwartz told NPR.

The related payments are expected in 2025 and will be financed from Philips' cash flow generation.

USA TODAY has contacted the attorneys for comment.

Philips stops production in the US: CPAP maker Phillips is entering a consent decree that will block the company from selling machines

Philips' years of legal back and forth

Philips announced a recall in 2021 for millions of its Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) and mechanical ventilators.

The recall was attributed to a possible defect in the devices, which could cause the foam used in them to deteriorate and cause inhalation of particles and fumes.

The FDA warned that ingesting sound-deadening foam comes with the risks of headaches, asthma and allergic reactions in addition to more serious problems, such as cancer. In February, the agency also released a report saying officials had received 116,000 complaints about the devices, more than 500 of which resulted in death, from people or lawyers who attributed the incidents to Philips' machines. The agency has since made it clear that further investigation into these claims is needed.

In a statement to USA TODAY at the time, Philips denied any connection between the deaths and injuries and its machines. The company previously said there had been no reports of deaths from product defects, but acknowledged that the risks of particulate exposure could cause “headaches, irritation, inflammation, respiratory problems and possible toxic and carcinogenic effects.”

Earlier this year, Philips agreed to a consent decree that blocked the company from selling sleep apnea machines in the United States and was ordered to offer a payment option as part of a recovery plan.

A 2023 investigation into the recall by Pro Publica and the Pittsburg Post Gazette found that Phillips had withheld complaints about the foam for more than a decade before warning customers.

Recalled devices

Existing devices manufactured between 2009 and April 2021 are subject to a recall as they may pose a serious risk of injury due to the breakdown of the PE-PUR foam used in them.

Devices involved in the recall include:

  • A series BiPAP A30
  • A series BiPAP A40 (ventilator)
  • A-series BiPAP hybrid A30
  • A series BiPAP V30 Auto (ventilator)
  • C Series ASV (Ventilator)
  • C series S/T and AVAPS
  • DreamStation
  • DreamStation ASV
  • DreamStation Go
  • DreamStation ST, AVAPS
  • Sleep 400
  • Sleep 500
  • E30
  • Garbin Plus, Air, LifeVent (fan)
  • OmniLab Advanced+
  • REMstar SE car
  • SystemOne ASV4
  • SystemOne (Q series)
  • Trilogy 100 (ventilator)
  • Trilogy 200 (ventilator)
  • Certain Trilogy Evo fans with specific serial numbers.

Some products that were modified in an attempt to resolve the problem have also been recalled. In particular, certain remanufactured Philips Respironics Trilogy 100/200 ventilators, as the FDA has requested additional safety testing on the silicone foam material used to replace the PE-PUR foam.

These products include:

Contributors: James Powell, Anthony Robledo and Adrianna Rodriguez.

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